Company/Organization Description

Bilayer Therapeutic, Inc. was formed to develop BL-010, a bile acid-based, first-in-class therapeutic for constipation and to deliver drugs for other diseases of the colon via a proprietary bilayer tablet technology. The team includes Robert Langer, Institute Professor at MIT and a world-renowned expert on drug delivery; Joshua Korzenik, MD, gastroenterologist and Director of the Crohn’s and Colitis Center at Brigham & Women’s Hospital (BWH), Harvard Medical School (HMS), and an expert on IBD; Giovanni Traverso, PhD/MD, Assistant Professor at MIT and a gastroenterologist at BWH, HMS and an expert in GI drug delivery; Dr. Christoph Steiger, an expert for drug formulation; Michael Camilleri, MD, a gastroenterologist and expert on bile acids at the Mayo Clinic, and Thomas A. Collet, PhD, a life science entrepreneur (Rubicon, NIT, ProNAi/Sierra Oncology SRRA). Constipation is a chronic condition that affects 15% of adults in the US. A prescription drug for the most serious presentations of this unmet need would address a US market potential of $5.4B (sales of $2.1B in 2019, global potential projected at >$20B in 2027). The potential for new products is illustrated by Linzess with 2021 US revenues of >$1B. Existing products are considered insufficient by patients and physicians. BL-010 is a first-in-class therapeutic comprised of chenodeoxycholate, a bile acid, for the treatment of chronic constipation. Delivery is via a proprietary bilayer tablet approach in an extended release format specifically to the colon. BL-010 is 6-9 months away from IND. Our approach is protected by two patent applications, one owned by MIT and BWH protecting the bilayer concept and one owned by Bilayer protecting a key step in manufacturing. We have already raised $3.6M in seed capital and are looking to finish this raise with another $2M to get to IND. This financing would be followed by a Series A of $15M early next year for human proof of concept of the bilayer approach.